A March Decision That Could Change Protalix BioTherapeutics Outlook
Protalix Bio Therapeutics (PLX) received a positive CHMP opinion for Elfabrio's every-four-weeks dosing in stable adult Fabry patients, pending EC approval by March. PLX's Elfabrio could halve infusion frequency, improving patient quality of life and potentially strengthening its competitive position in the Fabry market. Elfabrio drove over half of PLX's FY24 product revenue, with sales rising and a potential $25 million milestone tied to EU approval.
Protalix wins EU panel backing for expanded dosing of Fabry disease drug
Protalix Biotherapeutics Inc (NYSE-A:PLX, FRA:PBDA) said on Friday that the European Medicines Agency's human medicines committee has issued a positive opinion recommending approval of an expanded dosing regimen for Elfabrio, its treatment for Fabry disease, in adult patients. The Committee for Medicinal Products for Human Use (CHMP) recommended approval of a 2 mg/kg every-four-weeks dosing schedule for Elfabrio in adult Fabry patients who are stable on enzyme replacement therapy, following a re-examination of the application.
Protalix BioTherapeutics CEO outlines 2026 priorities, highlights progress across clinical pipeline
Protalix Biotherapeutics Inc (NYSE-A:PLX) on Monday shared an update from its CEO Dror Bashan, who highlighted the company's strategic priorities for 2026, with a focus on advancing its clinical pipeline while building on its partnered commercial base. In a letter to stockholders, Bashan wrote that Protalix remains focused on “building with our partners a growing, profitable business and an innovative pipeline for patients with high-need rare diseases.
Protalix BioTherapeutics partners with Secarna Pharmaceuticals on rare kidney disease drug development
Protalix Biotherapeutics Inc (NYSE-A:PLX) announced that it has entered into a collaboration and option agreement with Secarna Pharmaceuticals to jointly develop new antisense oligonucleotide (ASO) therapies targeting rare kidney diseases, the companies said Tuesday. Secarna, headquartered in Martinsried, Germany, specializes in the discovery and development of oligonucleotide-based therapeutics.
Protalix and Chiesi seek EMA re-examination of Elfabrio dosing opinion
Protalix Biotherapeutics Inc (NYSE-A:PLX) and Chiesi Global Rare Diseases said they have requested a re-examination of a recent negative opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) concerning a new dosing regimen for Elfabrio. The CHMP's opinion relates to a proposal to add a 2 mg/kg every-four-weeks (E4W) dosing option to the currently approved 1 mg/kg every-two-weeks (E2W) regimen for the treatment of adults with Fabry disease.
Protalix, Chiesi reaffirm commitment to Fabry disease patients after EMA panel setback
Protalix Biotherapeutics Inc (NYSE-A:PLX) and Chiesi Global Rare Diseases said they remain committed to advancing treatment options for Fabry disease after a European Medicines Agency committee declined to recommend approval of a new, less frequent dosing regimen for Elfabrio (pegunigalsidase alfa). The Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the proposed dosing schedule of 2 mg/kg every four weeks, in addition to the already approved 1 mg/kg every two weeks regimen.
Protalix: Speculative Buy On Promising Plant-Cell Platform And Elfabrio Ramp
Protalix BioTherapeutics uses a plant-cell approach with ProCellEx. This has given it two approved ERTs plus PRX-115 and PRX-119. Its main focus is on a growing rare-disease pipeline. The main value driver is Elfabrio, which targets Fabry's rapidly growing TAM. PLX's valuation multiples also look compelling, especially after the stock retraced significantly in the last few weeks.
Protalix BioTherapeutics, Inc. (PLX) Q2 2025 Earnings Call Transcript
Protalix BioTherapeutics, Inc. (NYSE:PLX ) Q2 2025 Earnings Call August 14, 2025 8:30 AM ET Company Participants Dror Bashan - President, CEO & Director Eyal Rubin - Senior VP, CFO, Treasurer & Corporate Secretary Conference Call Participants Daniel Robert Smith - H.C. Wainwright & Co, LLC, Research Division John D.
Protalix BioTherapeutics lifts revenue on strong Elfabrio demand
Protalix Biotherapeutics Inc (NYSE-A:PLX) reported higher quarterly revenue and reaffirmed its long-term growth outlook on Thursday, pointing to expanding demand for its Fabry disease treatment Elfabrio and upcoming clinical milestones for its pipeline. The Israeli biopharmaceutical company said revenue from selling goods rose 16% to $15.4 million in the quarter ended June 30, driven largely by increased sales of Elfabrio to Italian drugmaker Chiesi.
Protalix BioTherapeutics welcomes new finance chief
Protalix BioTherapeutics Inc (NYSE-A:PLX) has announced the appointment of Gilad Mamlok as senior vice president and chief financial officer, succeeding Eyal Rubin. Mamlok has already joined the company and is currently working alongside Rubin, the company said.
Protalix BioTherapeutics joins Russell 3000 and 2000 indexes following annual reconstitution
Protalix Biotherapeutics Inc (NYSE-A:PLX) announced that it has been added to the Russell 3000 and Russell 2000 Indexes, effective after the US market closed on Friday, June 27. The inclusion follows the annual reconstitution of the Russell indexes by global index provider FTSE Russell.
Protalix BioTherapeutics, Inc. (PLX) Q1 2025 Earnings Call Transcript
Protalix BioTherapeutics, Inc. (NYSE:PLX ) Q1 2025 Earnings Conference Call May 9, 2025 8:30 AM ET Company Participants Mike Moyer – Investor Relations Dror Bashan – President and Chief Executive Officer Eyal Rubin – Senior Vice President and Chief Financial Officer Conference Call Participants John Vandermosten – Zacks Operator Good morning, ladies and gentlemen, and welcome to the Protalix BioTherapeutics First Quarter 2025 Financial and Business Results Conference Call. As a reminder, this conference is being recorded.
